Saeshin Precision Co., Ltd. FDA Approvals

0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Motor Handpiece and Control Unit (SDI10)510(k)Jan 30, 2026Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jan 30, 2026
Traus SSG10 Surgical System510(k)Sep 20, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Sep 20, 2024
Traus SSG30 Surgical System510(k)Sep 16, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Sep 16, 2024
TRAUS Air Dental Handpiece510(k)Feb 22, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Feb 22, 2023
TRAUS ENDO510(k)Jun 24, 2022Dental	Dental	510(k)Substantially Equivalent (Special)	Jun 24, 2022
TRAUS SIP20510(k)Feb 11, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Feb 11, 2021